National access

A key challenge for a life sciences product manufacturer is to address the varying needs of each national market. The access professional has to understand and satisfy the requirements of these authorities and purchasers.

A good working understanding of the regulatory approval process is invaluable to the access practitioner. The marketing authorisation process in some regions such as the European Union may benefit from a central regulator, but the national regulator is a central player in deciding on the early access of a medicine. We describe international bodies in the section on international access, and the national regulator's role in each of our country pages.

The EU's Joint Clinical Assessment (JCA) procedure is currently being rolled out, initially for all new ATMPs and oncology medicines. From January 2028 orphan medicinal products will be included, and from January 2030 all other new drugs will have to go through this process. This assessment of the comparative clinical effectiveness of a medicine will be applicable across the EU region and means that individual countries will no longer be conducting their own clinical assessments for the relevant classes of drug. It remains to be seen how countries outside the EU respond to the joint clinical assessments but, for the time being, non-EU countries will continue to carry out their own clinical assessments.

While the comparative clinical assessment will increasingly be conducted centrally within the EU, and other regions may follow in combining their clinical assessments, individual countries will still be conducting their own economic appraisals and pricing negotiations, and commissioners of health care will still be deciding how and when to introduce new treatments.

Although each country differs in the details of these processes, there is a significant degree of commonality in the process itself. We therefore adopt a common structure to address these steps across the different countries, and in each of these sections we describe how they address each of these common elements of the access process, while proposing a typology of access approaches to help visualise the commonalities and distinguish differences across the countries.